Dendreon Expands Launch of Provenge

SEATTLE, March 10, 2011 /PRNewswire/ -- Dendreon
Corporation (Nasdaq:
DNDN) announced today that the
U.S. Food and Drug Administration (FDA) approved the remainder of
its New Jersey manufacturing
facility, allowing the company to significantly increase the
availability of PROVENGE® (sipuleucel-T) to help meet the needs
of patients with asymptomatic or minimally symptomatic metastatic
castrate resistant (hormone refractory) prostate
cancer.

Last April, upon receiving FDA approval of PROVENGE, Dendreon
launched the world's first patient-specific prostate cancer
immunotherapy from 12 workstations in its New Jersey facility. With the FDA
approval of 36 additional workstations, the New Jersey facility will now have a total of
48 approved workstations. Dendreon will bring these new
workstations online in a staged approach.

PROVENGE is designed to induce an immune response against
prostatic acid phosphatase (PAP), an antigen expressed in most
prostate cancers, and is the first in a new therapeutic class of
drugs known as autologous cellular immunotherapies.

"PROVENGE has the largest reported survival benefit in patients
with asymptomatic or minimally symptomatic metastatic prostate
cancer, with the most common side effects being primarily transient
and mild to moderate. As such, PROVENGE is the standard of care for
these patients," said Daniel George,
M.D., director of GU Medical Oncology and the Prostate Clinic at
Duke University Medical Center. "The
increased availability of PROVENGE will allow more treatment
centers and patients across the country to access this important
treatment option."

In anticipation of the availability of the additional
workstations, Dendreon expects to have approximately 225 infusion
centers prepared to treat their first patient by the end of the
second quarter, approximately 450 infusion centers upon entering
the fourth quarter, and approximately 500 by the end of 2011.

PROVENGE was approved based on three Phase 3 studies, including
the pivotal, 512-patient Phase 3 IMPACT study, which showed that
PROVENGE demonstrated a statistically significant improvement in
overall survival compared to control in men with asymptomatic or
minimally symptomatic metastatic castration resistant prostate
cancer (CRPC). That trial showed PROVENGE extended median survival
by 4.1 months compared to control. Overall, PROVENGE reduced
the risk of death by 22.5 percent compared to the control group
(HR=0.775). Results from the similarly designed Phase 3 Study D9901
in asymptomatic metastatic CRPC also demonstrated a survival
advantage of similar clinical magnitude as the IMPACT study.

"The significant 4.1 month median survival benefit PROVENGE
demonstrated represents a major milestone in the treatment of
metastatic CRPC. To put PROVENGE in perspective, over the past 15
years, there have only been three other therapies in any metastatic
cancer setting to show a survival benefit of four months or more,"
said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "With FDA
approval of the additional NJ workstations, we now have significant
capacity to make this important therapy available to the many men
across the U.S. who may benefit from it."

Dendreon expects to continue to provide additional capacity
through the anticipated licensure of its two other manufacturing
facilities. Dendreon filed a post-approval supplement on
February 28, 2011, requesting
licensure of 36 work stations in its Los
Angeles facility to manufacture PROVENGE and expects a
decision in mid-2011.

Dendreon also plans to file a post-approval supplement for its
third facility in Atlanta, which
is expected to come online in mid-2011.

PROVENGE is intended solely for autologous use and is not
routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate
cancer patients in four randomized clinical trials who underwent at
least one leukapheresis. The most common adverse events (incidence
greater-than or equal to 15%) are chills, fatigue, fever, back
pain, nausea, joint ache, and headache. Serious adverse events
reported in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion
reactions were reported in 3.5% of patients in the PROVENGE group.
Reactions included chills, fever, fatigue, asthenia, dyspnea,
hypoxia, bronchospasm, dizziness, headache, hypertension, muscle
ache, nausea, and vomiting. No Grade 4 or 5 acute infusion
reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the
company's ongoing commitment to patients, Dendreon will conduct a
registry of approximately 1500 patients to further evaluate a small
potential safety signal of cerebrovascular events. In four
randomized clinical trials of PROVENGE in prostate cancer patients,
cerebrovascular events were observed in 3.5% of patients in the
PROVENGE group compared with 2.6% of patients in the control
group.

For more information on PROVENGE, please see the full
prescribing information or call Dendreon ON Call at
1-877-336-3736.

About Prostate Cancer

According to the American Cancer Society, prostate cancer is the
most common non-skin cancer in men in the
United States and the third most common cancer worldwide.
More than two million men in the United
States have prostate cancer, with an estimated 217,730 new
cases and approximately 32,050 men expected to die from the disease
in 2010.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is
to target cancer and transform lives through the discovery,
development and commercialization of novel therapeutics. The
Company applies its expertise in antigen identification,
engineering and cell processing to produce active cellular
immunotherapy product candidates designed to stimulate an immune
response. Dendreon's first autologous cellular immunotherapy
product, PROVENGE® (sipuleucel-T), was approved by the FDA in
April 2010 for the treatment of
asymptomatic or minimally symptomatic metastatic,
castrate-resistant (hormone-refractory) prostate cancer. Dendreon
is also developing an orally-available small molecule that targets
TRPM8 that could be applicable to multiple types of cancer. The
Company is headquartered in Seattle,
Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq
Global Market under the symbol DNDN. For more information about the
Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that
are subject to risks and uncertainties. Factors that could affect
these forward-looking statements include, but are not limited to,
developments affecting Dendreon's business and prospects, including
commercialization of PROVENGE. Information on the factors and risks
that could affect Dendreon's business, financial condition and
results of operations are contained in Dendreon's public disclosure
filings with the U.S. Securities and Exchange Commission, which are
available atwww.sec.gov. Dendreon cautions
investors not to place undue reliance on the forward-looking
statements contained in this press release. All forward-looking
statements are based on information currently available to Dendreon
on the date hereof, and Dendreon undertakes no obligation to revise
or update these forward-looking statements to reflect events or
circumstances after the date of this press release, except as
required by law.

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